Taiwan headquartered specialty pharma Sunny Pharmtech (Sunny) announced today that it has successfully developed the generic version of AMICAR®, a fibrinolysis inhibitor, of Clover Pharmaceutical for the US market. Indications for AMICAR® include the inhibition of plasminogen activators which could cause hypoprothrombinemia. It can also be used in the treatment of abnormal bleeding syndromes from surgeries and other hematological diseases. Sunny also said that it has chosen Lotus Pharmaceutical (Lotus) to be its CMO partner in the commercialization of AMA.
Sunny is a vertically integrated specialty pharma that specializes in the development of both API and formulation. Commenting on the partnership, Chairman and CEO of Sunny, Dr. Yon-Lian Wu said, “We believe AMA is a complex generic because of its synthetic method and the manufacturing process purification of the chemical intermediate. Sunny invested in the development of AMA because we wanted to address the unmet needs of the patients and also because we saw market potential of this ANDA. We consider ourselves lucky to have found a partner who holds the same value.” He also said that Lotus is a company with global exposure, stringent quality standards, and manufacturing capabilities for difficult generics. Dr. Wu showed confidence in this partnership which “should provide benefit the hematology community in the US”.
Lotus Chairman Andrew Lin was excited about working together with such an experienced, dedicated team. He said, “We are proud to be exploring a less-served sector in the US with Sunny and together we hope to see more collaborations between local pharmaceuticals targeting regulated markets. Made In Taiwan for a much bigger market is only possible if we do it together.”